Maree Zinzley, Manager Approvals of the Ministry for Primary Industries (MPI), acting under delegated authority from the Director-General of MPI, gives notice under section 14(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 (“Act”) that the following variation application has been made to a registered trade name product under section 9(2) of the Act:

Trade Name: Kelaprofen 10%

Reference: A009851 – 8

Active Ingredient and Concentration:

Ketoprofen 100mg/mL

Formulation Type: Aqueous solution

General Use Claim:

Horses: Anti-inflammatory and analgesic treatment of musculoskeletal disorders, including: lameness of traumatic origin,arthrosis, arthritis, osteitis, spavin, navicular disease, tendonitis, bursitis, laminitis, myositis, post-surgical inflammation.Symptomatic analgesic treatment in colic, alone or associated with causal therapy.Symptomatic treatment of fever. Cattle: anti-inflammatory, analgesic and antipyretic treatment of respiratory disorders, acute mastitis, mammary oedema, colic, and musculoskeletal disorders.

Proposed New Claim:

Proposed new meat withholding period following intramuscular administration of 2 days.

Any person may make a written submission to the director-general concerning this application.

Under sections 16 and 17 of the Act, a written submission:

1. must state in full the reasons for making the submission;
2. may state any decision sought on that application; and
3. must be received by the director-general no later than 30 working days after the date of notification in the New Zealand Gazette.

Under section 18 of the Act, a copy of every submission will be forwarded to the applicant for the applicant’s information.

The following address is:

1. where submissions on this application are to be sent;
2. where requests for copies of the public information relating to the application can be sent;
3. where public information relating to the application can be viewed; and
4. the director-general’s address for service:

ACVM Group, Ministry for Primary Industries, Charles Fergusson Building, 34–38 Bowen Street, Pipitea, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140.

The applicant’s address for service is:

Kela N.V., Sint Lenaartseweg 48, 2320 Hoogstraten, Belgium. Postal Address: Phoenix Pharm Distributors Ltd., PO Box 31363, Milford, Auckland.

Dated at Wellington this 16th day of July 2021.

MAREE ZINZLEY, Manager Approvals, Ministry for Primary Industries (acting under delegated authority).